Regulatory and Quality Services for Biologics
Regulatory and Quality Services for BiologicsPharma biologics companies specialize in developing, producing, and marketing biologic drugs, which are medications derived from living organisms. Unlike traditional small-molecule drugs, biologics are typically large, complex molecules such as proteins, monoclonal antibodies, and vaccines. The company’s harness cutting-edge biotechnology techniques to create treatments that can target diseases with high specificity, offering new hope for patients with conditions that were previously difficult or impossible to treat effectively.
Masuu provide specialized regulatory and quality services for biologics, including monoclonal antibodies, vaccines, and cell therapies. Our team ensures your biologic products comply with stringent global standards, facilitating smooth market entry and post-approval maintenance.
We offer a comprehensive suite of services designed to support biologic companies at every stage of product development, from pre-market authorization to post-market surveillance:
- Regulatory Strategy Development
- We help Pharma biologic companies develop customized regulatory strategies tailored to their specific product type (e.g., monoclonal antibodies, vaccines, cell therapies), ensuring alignment with global regulatory agencies like the FDA, EMA, PMDA, and WHO.
- Market Access Plans: We create strategies that accelerate market access by ensuring that biologic products comply with relevant regulatory frameworks.
- Dossier Preparation and Submission
- Our team prepares Regulatory Dossiers for biologics, including BLA (Biologics License Applications) in the U.S. and MAA (Marketing Authorization Applications) in Europe. We ensure these submissions comply with the CTD (Common Technical Document) format, covering all necessary clinical, non-clinical, and manufacturing data.
- We handle pre-submission meetings with regulatory agencies and ensure that all required documentation is submitted in accordance with global guidelines.
- Biologics Manufacturing Support
- We assist biologic companies in ensuring their Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards are met, guaranteeing that products are manufactured safely and comply with global regulations.
- Our experts help ensure the validation and qualification of biologic manufacturing processes, reducing risks and ensuring product consistency.
- Clinical Trial Design and Support
- We guide biologic companies in the design, execution, and management of clinical trials for monoclonal antibodies, vaccines, and cell therapies, ensuring alignment with regulatory requirements.
- Our team assists with clinical trial applications (CTA), IND submissions, and trial data management, ensuring regulatory compliance throughout the clinical development phase.
- Post-Approval Monitoring and Compliance
- After product approval, Masuu Global provides post-market surveillance services to ensure ongoing compliance, including pharmacovigilance, adverse event reporting, and periodic safety reports (PSUR/PADER).
- We support the monitoring of product performance and ensure timely updates to regulatory authorities on any safety issues, ensuring continued patient safety and product efficacy.
- Regulatory Intelligence and Consulting
- Our team keeps you updated on the latest regulatory changes affecting biologics, providing actionable regulatory intelligence that enables you to stay compliant and competitive in the global market.
- Regulatory Consulting: We offer expert consultation on biologic-specific regulatory challenges, including product labeling, clinical trial data, and market-specific requirements.
- Labeling and Artwork Compliance
- We assist biological companies in preparing labeling and packaging for their products, ensuring that they meet international regulatory standards and are clearly understood by healthcare providers and patients.